Professor Anthony O’ReganConsultant Physician

Galway University HospitalIrish Thoracic Society Interstitial Lung Clinical Advisory Group

1st DataReported

ASMNov 2017

• `’ILD Group” meeting

• 1st Site Ethics Approval

• First Data Entered

• Registry Nurse

2014

Jan2016

• ITS ILD Group proposes Registry

• CFRI (Godfrey Fletcher & Ed McKone)

• Pharma: Unrestricted Grant

2015

• ILD Group Registry Proposal

• OpenApp Meeting

• Data Sheets approved at ITS ASM

• Ethics Application Test Site (GUH)

• Registry Built (OpenApp)

Sept2016

• Site 2 Ethics Approval

• Multidisciplinary Steering Committee established: • Decision to focus on IPF• Amendments to ethics, data sheets, & site folders

• Meeting OpenApp

• Site 3-5 Ethics Approval

• Committee Meeting

• More Amendments!!!

• Meeting OpenApp

• Service Fees agreed

Jan-Apr2017

• Site 6 Ethics Submitted

• Final Registry Sign off

• All Sites Ethics Amendments

Sept2017

XXXLimerick Regional Hospital

Galway UniversityHospital

Cork University Hospital

Adelaide & MeathHospital

Mater Hospital

St Vincent’s Hospital

– Objectives:• Clinical Features & Prognosis of IPF in Ireland

• Framework to evaluate management of IPF

• Develop reliable datasets to advocate for patient care

• Promote Research in IPF

• Integrate with International Registries / Groups

• Broaden focus to general ILD (overtime)

– Embed & Resource Governance

• Steering Group / Protocols / Audit Structure

– Ensure a National Registry using Specialist Centres

– Ensure reliable Data Collection

Reality of Capturing Data on Clinical Sites Lesson 1

Feasible focused Data Sets• All Interstitial Diseases vs Specific Disease (IPF)

• Establish Clinical Advisory / Steering Group – buy in!

• Prioritise Specific Aims & Objectives

Chair: Prof. A O’Regan, Galway University Hospital, Galway.Vice-Chair: Dr. Michael Henry, Cork University Hospital, Wilton, Cork.Secretary: Ms. Suzanne McCormack, CEO, Irish Thoracic SocietyCNS Rep: Ms. Bernadette Bowen CNS; Ms Lindsay BrowneExternal: Dr. Colin Edwards, CEO, Merlin Consulting Ltd., Dublin.Member : Ms. Carita Bramhill, St. Vincent’s University Hospital, DublinMember: Ms. Nicola Cassidy, Irish Lung Fibrosis Association, Dublin

Reality of Capturing Data on Clinical Sites Lesson 1

Feasible focused Data Sets• All Interstitial Diseases vs Specific Disease (IPF)

• Establish Clinical Advisory / Steering Group – buy in!

• Prioritise Specific Aims & Objectives

Reality of Capturing Data on Clinical Sites Lesson 2

Simplify Process of Data Collection

• Protocols & Site Folders (NCT registry)

• Clear Guidelines on Consent & Data Storage

• Facilitate Data Collection & Entry • Proforma

• ILD Nurse

IRISH THORACIC SOCIETY

ILD REGISTRY

CONTENTS PAGE

1. Contact list

2. Delegation log

3. Site personnel Curriculum Vitae

4. Protocol

5. Ethics:

A) Application

B) Amendments

C) Ethics Correspondence

6. Patient Information Leaflet and Consent Form

7. Staff Training Log

8. Recruitment Log

9. Note to File

10. Correspondence

11. Education Literature

12. Auditing

!The!Irish!Thoracic!Society!(ITS)!Interstitial!Lung!Disease!Registry!of!Ireland!!

!!

Information!for!Patients!You$are$being$invited$to$take$part$in$a$project$to$develop$a$patient$registry$(the$Irish$Thoracic$Society$Interstitial$Lung$Disease$Registry$of$Ireland)$for$people$with$Interstitial$Lung$Disease$(ILD)$which$includes$Idiopathic$Pulmonary$Fibrosis$(IPF).$You$are$being$invited$to$take$part$because$you$have$Idiopathic$Pulmonary$Fibrosis.$It$is$important$that$you$read$the$following$information$about$why$the$registry$is$taking$place$and$what$it$entails,$before$you$decide$whether$or$not$to$take$part.$$Please$read$the$following$information$carefully$and$discuss$it$with$others$if$you$wish.$You$are$also$free$to$ask$us$any$questions$you$may$have$or$to$clarify$anything$you$may$not$understand.$Do$take$the$time$to$decide$whether$or$not$you$wish$to$take$part$in$this$project.$!What!is!the!ITS!Interstitial!Lung!Disease!Registry!of!Ireland?!The$ITS$Interstitial$Lung$Disease$Registry$collects$and$analyses$information$relating$to$health$and$wellbeing$of$people$with$ILD$including$Idiopathic$Pulmonary$Fibrosis$in$Ireland.$Information$relating$to$the$prevalence,$incidence$and$treatment$of$idiopathic$pulmonary$fibrosis$will$be$stored$in$the$registry.$The$information$is$held$on$a$secure$and$confidential$computer$database.$The$development$and$maintenance$of$the$registry$is$led$by$the$Irish$Thoracic$Society$with$support$from$Boehringer$Ingelheim$Ireland.$$Why!have!an!Interstitial!Lung!Disease!Registry??!Since$Interstitial$Lung$Disease,$which$includes$Idiopathic$Pulmonary$Fibrosis,$affects$a$relatively$small$number$of$people,$by$creating$this$registry,$we$can$compile$information$to$advance$education$and$facilitate$research$on$the$disease.$By$analyzing$the$data$we$collect,$we$will$be$better$able$to$see$what$actions$are$successful$and$how$treatments$affect$different$people.$From$there,$doctors$can$better$help$contribute$to$the$quality$of$care$of$persons$with$Idiopathic$Pulmonary$Fibrosis.$!What!information!is!kept!in!the!ITS!Interstitial!Lung!Disease!Registry!of!Ireland??!The$information$collected$will$resemble$that$collected$in$a$general$doctor$or$hospital$visit:$demographics,$height,$weight,$pulmonary$function$tests,$respiratory$cultures$and$any$other$tests$carried$out.$The$registry$will$also$store$information$on$any$drugs$taken$or$treatments$given$as$well$as$any$complications$that$arise.$$$Do!I!have!to!take!part?!It$is$your$decision$to$take$part$or$not$take$part$in$the$Interstitial!Lung!Disease!Registry?.$Your$care$will$not$be$affected$in$any$way$if$you$choose$to$not$take$part.$If$you$do$decide$to$take$part,$you$will$be$given$this$information$sheet$to$keep$and$will$be$asked$to$sign$a$consent$form.$$$Can!I!change!my!mind!later?!If$you$agree$to$take$part$in$the$Interstitial$Lung$Disease$registry,$you$may$choose$to$withdraw$at$any$point$in$the$future$without$providing$a$reason.$Any$information$stored$on$you$will$then$be$

The$Irish$Thoracic$Society$Interstitial$Lung$Disease$Registry$of$Ireland$(ILDRI)$

!

!

CONSENT$FORM$

This!purpose!of!this!registry!and!consent!

form!has!been!explained!to!me.!I!have!

read,!or!had!read!to!me,!this!consent!

from.!!I!have!had!the!opportunity!to!ask!

questions!and!all!my!questions!have!

been!answered!to!my!satisfaction!

I!believe!I!understand!what!will!happen!if!

I!agree!to!be!part!of!this!registry.!

I!understand!that!I!can!withdraw!from!

this!registry!at!any!time!

I!freely!and!voluntarily!agree!to!be!part!

of!this!registry,!though!without!prejudice!

to!my!legal!and!ethical!rights.!!

I!have!received!a!copy!of!this!agreement!

and!I!understand!a!copy!will!be!kept!by!

the!principal!investigator!at!this!study!

site.!

Name!Principal!Investigator!!

___________________________!Name!

Hospital!Site!

___________________________!!

ILD!Registry!Office:!!

Prof.!Anthony!O’Regan,!Irish!Thoracic!

Society,!Brookfield!House,!Brookfield!

Terrace,!Blackrock,!Co!Dublin!

!

!

!

!

!

Interstitial!Lung!Disease!Registry!of!Ireland,!!

Irish!Thoracic!Society,!!

Brookfield!House,!Brookfield!Terrace!

Blackrock!

Co!Dublin!

Participants*Name:*

Participants*Date*of*Birth:*

Signature*of*Participant:*

Date:*

*

Name*of*consentor:*

Signature*of*consentor:*

Relationship*to*participant:*

Date:*

Statement$of$Investigators$responsibility:$I!have!explained!the!nature,!purpose,!procedures,!benefits,!risks!of!

alternatives!to,!this!registry.!I!have!offered!to!answer!any!questions!and!

fully!answered!such!questions.!I!believe!that!the!participant!understands!

my!explanations!and!has!freely!given!informed!consent.!*

Signature*of*physician:*

Date:*

The!original!consent!form!should!be!placed!in!the!participants!medical!

records,!one!copy!may!be!given!to!the!participant,!and!one!copy!kept!by!the!

principal!investigator!at!the!study!site.!.!*

Reality of Capturing Data on Clinical Sites Lesson 3

Working with Patient Organisations

• Irish Lung Fibrosis Association (ILFA)

• Irish Lung Health Alliance

• Seek input & Provide Patient Updates

• Develop Audit Structures (data protection)

Registry Comparison UK 2013-17

UK Ireland

Incidence (prevalence) 6000/yr (25-32000) 400/year (1-2000) estimate

Data Capture 9785-6% of new cases / yr3% of all cases

155??6-12% of cases

New diagnosis?

Age 72 72

Gender (male) 76% 69%

Smoker (Ex) 70% 58% Female data

FHx 7% 19% Higher

MDT 92% 80% lower

Definite 42% New verson

Biopsy 13% 10% (44% if cryobx) similar

FVC (50-80%) 57% (<50%: 4%) 52% (<50%: 2%) similar

DLCO (36-55%) 47% (<36%: 24%) 52% (<36% 26%) similar

Anti-fibrotic 45% 72% NICE

Thank you

• Suzanne McCormack

• Steering Group

• Bridget Mulholland (ILD Nurse)

• OpenApp

• Cystic Fibrosis Registry

Godfrey Fletcher & Ed McKone

• Boehringer Ingelheim (John Barron)

• Roche Pharmaceuticals (Denise Eggleston)